Detrusor Nerve Radiofrequency Ablation for Overactive Bladder in Women

NCT07209397 | Recruiting FDA Device

• 1 other identifier: DO614953A
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 9

Brief Summary

The goal of this clinical trial is to learn if a vaginal radiofrequency (RF) device called MORPHEUSV works to treat overactive bladder (OAB) in women. Researchers also want to learn how safe the device is for this indication. This study will include women ages 22 to 80 who have had OAB symptoms for at least 6 months. The main questions it aims to answer are: Does the MORPHEUSV device lower the number of daily episodes of accidental urine leakage caused by urgency? Does it work better than a sham (placebo) treatment? Researchers will compare the MORPHEUSV device to a sham treatment to see how well it reduces symptoms of overactive bladder. Participants will: 1) Receive one session of either the MORPHEUSV or sham treatment. 2) Track their symptoms using a diary and questionnaires 3) Return for three to six follow-up visits over 12 months. This study is being conducted at multiple clinics in the United States.

Conditions

Overactive Bladder; Urge Urinary Incontinence; Mixed Urinary Incontinence (Urge-Predominant); Mixed Urinary Incontinence; Idiopathic Overactive Bladder With Urinary Incontinence; Idiopathic Overactive Bladder; Overactive Bladder (OAB)

Keywords

Overactive bladder; Urge urinary incontinence; Mixed urinary incontinence; Female urinary symptoms; urogynecology; Female Urology

Outcome Measures

Primary Outcomes (1)

• Proportion of participants achieving ≥50% reduction in weekly urge urinary incontinence (UUI) episodes

  The percentage of participants who achieve at least a 50% reduction from baseline in the number of UUI episodes per week, as recorded in a 7-day bladder diary. This is the primary efficacy endpoint used to evaluate the effectiveness of the MORPHEUSV device compared to sham.

  6 months post-treatment

Secondary Outcomes (6)

• Change from baseline in mean number of UUI episodes per week

  6 months

• Change from baseline in mean number of urgency episodes per week

  6 months

• Change from baseline in mean number of micturitions per 24 hours

  6 Months

• Change from baseline in Incontinence Quality of Life (I-QOL) total score

  6 Months

• Change from baseline in Urgency Perception Scale (UPS) score

  6 Months

Study Arms (2)

MORPHEUSV Treatment Arm

ACTIVE COMPARATOR

Participants in this arm will receive a single session of radiofrequency (RF) treatment using the MORPHEUSV device. The treatment is delivered vaginally using a bipolar RF applicator at a therapeutic energy setting. No anesthesia is required. Participants will be followed for 12 months to evaluate safety and effectiveness.

Device: Detrusor nerve radiofrequency ablation

Sham Control Arm

SHAM COMPARATOR

Participants in this arm will undergo a procedure using a visually identical MORPHEUSV applicator, but without RF energy delivery (sham). The procedure mimics the appearance and duration of the active treatment. Participants will be followed for 12 months. After completing the 6-month follow-up, they may elect to cross over and receive a single session of the active RF treatment.

Device: Simulated (sham) detrusor nerve radiofrequency ablation

Interventions

Detrusor nerve radiofrequency ablation DEVICE

A single, vaginal radiofrequency (RF) treatment. The procedure is performed with a bipolar RF applicator and requires no anesthesia. Delivered in a single session in an outpatient setting.

MORPHEUSV Treatment Arm

Simulated (sham) detrusor nerve radiofrequency ablation DEVICE

A simulated (sham) radiofrequency (RF) treatment, but with no energy delivered. The procedure mimics the appearance, duration, and positioning of the active device, without therapeutic effect.

Sham Control Arm

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female, aged 22 to 80 years inclusive at the time of consent.
• History of idiopathic overactive bladder (OAB) symptoms for ≥6 months.
• At least 7 episodes of urge urinary incontinence (UUI) over 3 days, as recorded in a 3-day bladder diary during screening.
• Urge-predominant incontinence, defined as greater number of UUI episodes than stress urinary incontinence (SUI) episodes during screening.
• Willing and able to complete the 3-day bladder diary.
• Willing to discontinue OAB medications (e.g., anticholinergics, beta-3 agonists) at least 2 weeks prior to baseline treatment visit, if currently taking such medications.
• Willing to use a reliable method of contraception during the study period, if of childbearing potential and sexually active.
• Negative pregnancy test at screening (if applicable).
• Willing and able to provide written informed consent and comply with study procedures and follow-up schedule.

You may not qualify if:

• Predominant stress urinary incontinence (SUI) based on bladder diary
• Currently pregnant, breastfeeding, or planning pregnancy during the study
• History of neurologic conditions affecting bladder function (e.g., multiple sclerosis, spinal cord injury, Parkinson's disease)
• Active urinary tract infection (UTI) at screening
• History of interstitial cystitis, bladder pain syndrome, or chronic pelvic pain
• Prior or current bladder cancer, pelvic malignancy, or pelvic radiation
• Pelvic organ prolapse beyond the hymen (POP-Q stage \> II)
• Implanted neuromodulation device or prior sacral nerve stimulation
• Use of bulking agents, Botox, or surgical treatment for incontinence within 12 months
• Prior pelvic floor RF treatment or laser vaginal rejuvenation
• Significant pelvic anatomical abnormalities that interfere with treatment
• Use of investigational drug or device within 30 days before screening
• Any condition that, in the investigator's opinion, would interfere with safe study participation or data integrity
• Uncontrolled systemic disease (e.g., uncontrolled diabetes, cardiovascular disease)
• Inability or unwillingness to comply with study requirements or follow-up

Sponsors & Collaborators

• InMode MD Ltd.: lead
• Foundation for Female Health Awareness: collaborator

Study Sites (9)

Stanford Medicine Department of Obstetrics & Gynecology

Palo Alto, California, 94304, United States

NOT YET RECRUITING

MedStar Health Research Institute

Washington D.C., District of Columbia, 20010, United States

NOT YET RECRUITING

Advanced Specialty Research

Boise, Idaho, 83702, United States

RECRUITING

University of Chicago Medicine Urogynecology

Chicago, Illinois, 60062, United States

NOT YET RECRUITING

Cypress Medical Research Center

Wichita, Kansas, 67226, United States

RECRUITING

Bay State Clinical Trials

Watertown, Massachusetts, 02472, United States

RECRUITING

Urology Center, P.C.

Omaha, Nebraska, 68114, United States

RECRUITING

UNLV Kirk Kerkorian School of Medicine Department of Gynecologic Surgery & Obstetrics

Las Vegas, Nevada, 89154, United States

NOT YET RECRUITING

Atrium Health Wake Forest Female Pelvic Health Division

Winston-Salem, North Carolina, 27103, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders

Study Officials

• Mickey Karram, MD

  Foundation for Female Health Awareness (FFHA)

  STUDY DIRECTOR

Central Study Contacts

FFHA Study Manager

CONTACT

573-300-9185; nicholas@femalehealthawareness.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a 2:1 ratio to receive either a single session of the MORPHEUS V radiofrequency (RF) treatment or a sham procedure. The study uses a parallel assignment model in which participants remain in their assigned group through the 6-month primary endpoint. After completing the 6-month visit, participants in the sham group may elect to cross over and receive the active treatment. All participants will be followed for 12 months from the time of their initial intervention to assess safety and durability of treatment effects.

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 7, 2025
• Study Start: November 25, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: January 30, 2026

Record last verified: 2025-08

Locations

US (9)